NCT Number: NCT02643199
Automated Fetal Heart Echocardiography by Five-Dimensional Ultrasound in the Third Trimester of Pregnancy
The aim of the study to evaluate Five-Dimensional Ultrasound in automated assessment of the fetal heart from 20-36 weeks of gestation.
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Notify MeKey information
Age range
18 year–38 year
Sex eligibility
Female
Study type
Observational
About this study
This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.
90 pregnant women will be recruited from the Fetal Care Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.
All cases will be subjected to:
- Full history taking including patient's age, parity, last menstrual period, estimated gestational age by dates, past history of medical disorders, clinical examinations (General and abdominal).
- Two-Dimensional Ultrasound and Five-Dimensional Ultrasound will be done for all cases for assessment of fetal Heart.
- 90 consecutive patients will undergo 2D fetal echocardiography by one observer
- Then they will undergo blindly Five-Dimensional fetal echocardiography by another observer
- The data collected will be compared to evaluate the accuracy of Five-Dimensional US in fetal heart assessment.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Singleton pregnancy.
- Gestational age at 34-36 weeks as determined be date and last menstrual period.
- Normal Amniotic Fluid Index.
Exclusion criteria
- Multiple pregnancies.
- Oligohydramnios or Polyhydramnios (AFI > 95th percentile or < 5th percentile).
- Obese patient, BMI > 30
- Intrauterine growth restriction.
- Fetal spine between the 11- and 1- O'clock positions due to possibility of shadowing from ribs or spine
Treatment and study plan
Primary outcomes
-
Number of Satisfactory Fetal Echocardiography Views by Two-Dimensional Ultrasound
Time frame: 20 - 36 weeks of gestation
Fetal Echocardiography by Two-Dimensional Ultrasound measurement was done to examine fetal heart in both sagittal Views and transverse views:
- Four chamber view
- Five chamber view
- Left outflow tract
- Right outflow tract
- 3 vessels and Trachea View
- Abdomen/Stomach
- Ductal arch
- aortic arch
- Bicaval view then we count howmuch views of nine views were satisfactory
Secondary outcomes
-
Number of Satisfactory Fetal Echocardiography Views by Five-Dimensional Ultrasound
Time frame: 20 - 36 weeks of gestation
Fetal Echocardiography by Five-Dimensional Ultrasound measurement was done to examine fetal heart in both sagittal Views and transverse views:
- Four chamber view
- Five chamber view
- Left outflow tract
- Right outflow tract
- 3 vessels and Trachea View
- Abdomen/Stomach
- Ductal arch
- aortic arch
- Bicaval view then we count howmuch views of nine views were satisfactory
Sponsors and collaborators
Lead sponsor
Ain Shams University
Other
Registry information
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Dec 31, 2015
- Registry last updated
- Jul 14, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.